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NCT01408849 Clinical Trial

Use of Maytenus Ilicifolia in the Treatment of Dyspepsia

Dyspepsia Clinical Trial

Official title:
Use of Maytenus Ilicifolia Mart. ex Reiss in the Treatment of Dyspepsia

Clinical Trial Details — Status: Terminated

Administrative data
NCT number NCT01408849
Other study ID # Maytenus2011
Secondary ID
Status Terminated
Phase Phase 2
First received July 29, 2011
Last updated July 25, 2016
Start date February 2015
Est. completion date January 2016

Study information
Verified date July 2016
Source Casa Espirita Terra de Ismael
Contact n/a
Is FDA regulated No
Health authority Brazil: Conselho Nacional de Etica em Pesquisa (CONEP)
Study type Interventional

Clinical Trial Summary

This study aims to evaluate the therapeutic effect of the infusion of Maytenus ilicifolia Mart. ex Reiss leaves, used for 8 weeks, on patients with dyspepsia. Primary endpoint is SODA score, secondary endpoint is endoscopic classification (Sydney).

Recruitment information / eligibility
Status Terminated
Enrollment 4
Est. completion date January 2016
Est. primary completion date January 2016
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility Inclusion Criteria:

- age > 18 years

- being literate

- diagnosis of dyspepsia

- initial SODA score > or = 25

Exclusion Criteria:

- pregnancy

- lactation

- allergy to Maytenus species

- fail to use the drug for 3 uninterrupted weeks

- new onset serious adverse events, attributable to the drug

- patient's request

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• Maytenus ilicifolia leaves infusion
2 g of powdered leaves in 150 mL of boiling water, 3 times a day, for 8 weeks
• Omeprazole
Standard therapy

Locations
Country Name City State
Brazil Hospital das Clinicas FMRP-USP Ribeirao Preto SP

Sponsors (2)
Lead Sponsor Collaborator
Casa Espirita Terra de Ismael University of Sao Paulo

Country where clinical trial is conducted

Brazil, 

Outcome
Type Measure Description Time frame Safety issue
Primary SODA score 8 weeks No
Secondary Sydney classification 8 weeks No
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